Annual Report for Fiscal Year 2017

A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the United States

During FY 2017, ICCVAM coordinated the development of a strategic roadmap for incorporating new approaches into safety testing of chemicals and medical products in the United States. Sixteen federal agencies and multiple interagency workgroups, with input from a broad range of stakeholder groups, developed the roadmap.

The roadmap creates a framework that guides the development of enabling technologies and promotes strategies to establish confidence in and ensure utilization of new approaches to toxicity testing that improve human health relevance and reduce or eliminate the need for testing in animals. The successful development and implementation of these new approaches will require coordinated efforts that address three strategic goals:

Foster the use of efficient, flexible, and robust practices to establish confidence in new methods.

Connect users with developers of new approach methodologies.

Encourage the adoption and use of new methods and approaches by federal agencies and regulated industries.

The roadmap was first proposed to the Scientific Advisory Committee on Alternative Toxicological Methods (SACATM) in 2015. SACATM expressed support for the development of the roadmap as an ICCVAM activity at its September 2016 meeting. A meeting of ICCVAM members and other federal employees in February 2017 established an outline for the roadmap. Opportunities for public comment during development of the roadmap occurred during the annual meeting of the Society of Toxicology in March, ICCVAM Public Forum in May, NTP Board of Scientific Counselors meeting in June, and SACATM meeting in September.

The final roadmap document was published in January 2018 and is available on the NTP website.

Activities are underway to address the roadmap goals. Presentations at the September 2017 SACATM meeting described implementation of the roadmap for skin sensitization and acute systemic toxicity testing. Reviews of U.S. agency information requirements for these areas are being prepared and are planned for publication in FY 2018.

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